Regulatory and Quality Compliance Consultant (Medical Device Industry exp req)

Raleigh/Durham, NC | Full-time

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Regulatory and Quality Compliance Consultant (Medical Device Industry exp req)
Location: Raleigh / Durham, NC
Salary: $80,000 - $100,000 DOE + Quarterly and Yearly Performance Bonuses + Benefits
Benefits: Medical, 401K w/3% Match, Holidays, Vacation, Profit Sharing
Start Date: ASAP
Job Type: Full Time
Typical Hours: Monday – Friday, 8:30 AM – 6:00 PM
Sponsorship not available
No Remote Work

Relocation Assistance Available

Regulatory and Quality Compliance Consultant (Medical Device Industry exp req) Description

Our client is looking for a Regulatory and Quality Compliance Consultant to join their passionate and dedicated team in the Raleigh / Durham NC area. In this role, you will work directly with quality and regulatory company executives who are developing medical devices and providing consulting services to move the products through the regulatory processes. If you enjoy working with a collaborative team focused on execution and are looking for a company where you have growth and can build a career, then this is the position for you.

Regulatory and Quality Compliance Consultant (Medical Device Industry exp req) Responsibilities

• Meet client timelines across a wide diversity of projects and medical device products
• Develop regulatory roadmaps, assessments and strategies
• Implement quality assurance and regulatory affairs deliverables
• Develop Medical Device or Combination Product submissions for clearance or approvals
• Implement QMS components in compliance with US FDA and Global Quality System Regulations including 21 CFR Part 820 and ISO 13485:2016
• Develop or author Verification and Validation activities for medical devices and software
• Develop human factors engineering studies
• Develop and/or implement regulatory and quality gap assessments and remediation strategies

Regulatory and Quality Compliance Consultant (Medical Device Industry exp req) Qualifications

• Bachelor’s Degree Required (focus on Biomedical Engineering, or Computer or Electrical Engineering Preferred)
• 3+ years Quality Management experience required
• 3+ years of medical device industry experience
• 1+ years of 21 CFR Part 820 / ISO 13485:2016 or FDA product / CE mark submissions experience required
• Understanding of Software Development Life Cycle and software design a plus
• Human factors engineering studies experience a plus
• Experience with consulting engagements a plus